ID

14294

Descripción

Effect of Montelukast on Experimentally-Induced RV16 Infection in Asthma; ODM derived from: https://clinicaltrials.gov/show/NCT00359073

Link

https://clinicaltrials.gov/show/NCT00359073

Palabras clave

Versiones (1)
  1. 7/4/16 7/4/16 -
Titular de derechos de autor

CC BY-NC 3.0

Subido en

7 de abril de 2016

DOI

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Licencia

Creative Commons BY-NC 3.0
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Eligibility Asthma NCT00359073

Inglés

Eligibility Asthma NCT00359073

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00359073
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
a subject with mild persistent asthma is eligible for participation in the study if all of the following inclusion criteria apply:
Descripción

mild persistent asthma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1960046
male or female with no health concerns that might affect the outcome of the study
Descripción

health status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0018759
age 18-65 range
Descripción

age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
diagnosis of mild persistent asthma based on clinical findings such as cough, wheeze and shortness of breath
Descripción

mild persistent asthma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1960046
a history of asthma for at least six months prior to screening
Descripción

history of asthma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0004096
fev1> 80% of predicted
Descripción

fev1

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0748133
presence of allergy based on at least one positive prick skin test when tested with a standard panel of common allergens
Descripción

allergy, prick skin test

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0430561
UMLS CUI [2]
C0020517
ability to produce sputum when induced during the baseline assessments
Descripción

ability to produce sputum

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0038056
asthma medications consisting of only inhaled short acting b-agonist taken as needed
Descripción

inhaled short acting b-agonist

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2936789
reversible airways disease as indicated by > 12% reversibility post b-agonist or
Descripción

reversible airway disease

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0205343
UMLS CUI [1,2]
C0699949
UMLS CUI [2]
C2599594
methacholine hyperresponsiveness (pc20 < 8 mg/ml)
Descripción

methacholine hyperresponsiveness

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0430567
ability to give valid informed consent to participate by signing and dating a written consent form
Descripción

ability to give valid informed consent to participate by signing and dating a written consent form

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
a subject is not eligible to participate in this study if any of the following exclusion criteria apply:
Descripción

exclusion criteria

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0680251
history of severe episodes of asthma with respiratory infections
Descripción

severe episodes of asthma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0205082
screening serum rv16 antibody titer > 1
Descripción

rv16 antibody

Tipo de datos

boolean

current smoker or has a smoking history exceeding 5 pack years
Descripción

smoking history

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1519384
UMLS CUI [2]
C3241966
currently receiving immunotherapy
Descripción

immunotherapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0021083
currently participating in another clinical trial or has participated in an investigational drug trial within one month of screening
Descripción

participation status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2348568
unable, in the judgment of the investigator, to comply with directions and/or tolerate the procedures required for participation in this trial
Descripción

unable to comply

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1321605
pregnant or breast-feeding or has a planned pregnancy during the course of the study
Descripción

pregnancy or lactation or intention to become pregnant

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0032961
UMLS CUI [3,2]
C1283828
regular use of an asthma controller such as montelukast or an inhaled corticosteroid.
Descripción

asthma controller

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0004096
UMLS CUI [1,2]
C0013227
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Similar models

Eligibility Asthma NCT00359073

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Asthma NCT00359073
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
mild persistent asthma
Item
a subject with mild persistent asthma is eligible for participation in the study if all of the following inclusion criteria apply:
boolean
C1960046 (UMLS CUI [1])
health status
Item
male or female with no health concerns that might affect the outcome of the study
boolean
C0018759 (UMLS CUI [1])
age
Item
age 18-65 range
boolean
C0001779 (UMLS CUI [1])
mild persistent asthma
Item
diagnosis of mild persistent asthma based on clinical findings such as cough, wheeze and shortness of breath
boolean
C1960046 (UMLS CUI [1])
history of asthma
Item
a history of asthma for at least six months prior to screening
boolean
C0262926 (UMLS CUI [1,1])
C0004096 (UMLS CUI [1,2])
fev1
Item
fev1> 80% of predicted
boolean
C0748133 (UMLS CUI [1])
allergy, prick skin test
Item
presence of allergy based on at least one positive prick skin test when tested with a standard panel of common allergens
boolean
C0430561 (UMLS CUI [1])
C0020517 (UMLS CUI [2])
ability to produce sputum
Item
ability to produce sputum when induced during the baseline assessments
boolean
C0038056 (UMLS CUI [1])
inhaled short acting b-agonist
Item
asthma medications consisting of only inhaled short acting b-agonist taken as needed
boolean
C2936789 (UMLS CUI [1])
reversible airway disease
Item
reversible airways disease as indicated by > 12% reversibility post b-agonist or
boolean
C0205343 (UMLS CUI [1,1])
C0699949 (UMLS CUI [1,2])
C2599594 (UMLS CUI [2])
methacholine hyperresponsiveness
Item
methacholine hyperresponsiveness (pc20 < 8 mg/ml)
boolean
C0430567 (UMLS CUI [1])
ability to give valid informed consent to participate by signing and dating a written consent form
Item
ability to give valid informed consent to participate by signing and dating a written consent form
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
exclusion criteria
Item
a subject is not eligible to participate in this study if any of the following exclusion criteria apply:
boolean
C0680251 (UMLS CUI [1])
severe episodes of asthma
Item
history of severe episodes of asthma with respiratory infections
boolean
C0004096 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
rv16 antibody
Item
screening serum rv16 antibody titer > 1
boolean
smoking history
Item
current smoker or has a smoking history exceeding 5 pack years
boolean
C1519384 (UMLS CUI [1])
C3241966 (UMLS CUI [2])
immunotherapy
Item
currently receiving immunotherapy
boolean
C0021083 (UMLS CUI [1])
participation status
Item
currently participating in another clinical trial or has participated in an investigational drug trial within one month of screening
boolean
C2348568 (UMLS CUI [1])
unable to comply
Item
unable, in the judgment of the investigator, to comply with directions and/or tolerate the procedures required for participation in this trial
boolean
C1321605 (UMLS CUI [1])
pregnancy or lactation or intention to become pregnant
Item
pregnant or breast-feeding or has a planned pregnancy during the course of the study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C1283828 (UMLS CUI [3,2])
asthma controller
Item
regular use of an asthma controller such as montelukast or an inhaled corticosteroid.
boolean
C0004096 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
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